Vaginal pessary

ABSTRACT

A compactable vaginal pessary for managing pelvic organ prolapse is provided. The compactable pessary easily expands once inside a patient&#39;s vagina, remaining firmly anchored in the vaginal cavity during movement, thereby effectively countering the effects of any prolapsing organ. In a first embodiment, the vaginal pessary employs an expandable and collapsible frame member, while in a second embodiment; the frame member is an open, substantially cone-shaped, collapsible frame member that is biased to an open position. In a third embodiment, the compactable vaginal pessary is a yieldably extensible, self-retracting pessary. The vaginal pessary of the present invention may be easily inserted and removed by a patient on a daily basis, or as needed, thereby facilitating good hygiene and thus reducing or eliminating common pessary related complications.

RELATED APPLICATIONS

This application is a divisional application of, and claims priority to,U.S. patent application Ser. No. 12/482,043, filed Jun. 10, 2009, whichis a continuation-in-part application of, and claims priority to,International Application No. PCT/US2007/026016, filed Dec. 19, 2007,which in turn claims priority to U.S. Provisional Patent ApplicationSer. No. 60/871,272, filed Dec. 21, 2006, all of which are fullyincorporated herein by reference.

TECHNICAL FIELD

The present invention generally relates to a vaginal pessary formanaging pelvic organ prolapse, and more particularly relates to avaginal pessary that may be easily inserted and removed by a patient ona daily basis, or as needed, thereby facilitating good hygiene and thusreducing or eliminating common pessary related complications.

BACKGROUND AND SUMMARY OF THE INVENTION

The pelvic floor is a group of muscles, ligaments and connective tissuesthat together support the pelvic organs. In women, the pelvic floormuscles form a supportive sheet to keep the bladder, the rectum and theuterus in place. These muscles are attached to the fixed framework ofthe pelvic bones.

Pelvic organ prolapse or POP occurs when the pelvic floor muscles areweakened thereby allowing one or more of these pelvic organs to pushagainst the weakened wall of the vagina. POP, although not usually lifethreatening, affects urinary, sexual, and colorectal functions. Forwomen with significant complaints, the management of POP currentlyconsists of use of surgical reconstruction or vaginal pessaries.

Vaginal pessaries (i.e., plastic or silicone devices that are insertedinto the vagina to help support the vaginal walls and pelvic organs) areused for POP reduction in women who prefer conservative treatment.Periodic removal of these devices, however, is necessary to maintaingood hygiene and to reduce or eliminate complications caused at least inpart by the prolonged presence of these devices in the vagina, suchcomplications including irritation, erosion, bleeding and malodorousdischarge. Ideally, pessaries should be removed on a daily basis.

Unfortunately, a majority of prior art pessaries must be manuallysqueezed or bent in order to be inserted or removed from the body, thusmaking self-insertion almost impossible, especially for older women. Infact, only about 5% of patients are able to remove and reinsert theirown pessaries, with the majority of patients forced to rely on lifelongregular office visits every two to three months, with each visitincluding removal, cleaning and reinsertion of the pessary along with athorough inspection of the vagina. Even in the most experienced hands,removal is very difficult, and sometimes inhumane by today's standards.Most of the time, patients leave the office with small but painfulabrasions of the vaginal introitus. This stressful experience is themain reason for pessary discontinuation, and consideration of areconstructive surgical procedure.

In view of the above, it is a general object of the present invention toprovide a vaginal pessary that avoids the drawbacks associated withthese prior art pessaries.

It is a more particular object to provide a vaginal pessary that: (a) iseasy for a patient to insert and remove from the vaginal cavity; (b)remains firmly anchored in the vaginal cavity during movement, such ascoughing, sneezing, laughing, or during exercise; and (c) moreeffectively controls POP, whether in the form of cystoceles (herniationof the urinary bladder through the wall of the vagina), rectoceles(herniation of the rectum into the vagina), uterine prolapse, and/orvaginal prolapse.

It is another more particular object to provide different embodiments ofthe inventive vaginal pessary, all of which satisfy the objectsidentified above.

The present invention therefore provides a compactable vaginal pessarythat easily expands once inside a patient's vagina, that can be removed,cleaned and reinserted daily, or as needed, by the patient.

In a first embodiment, the vaginal pessary of the present inventionbasically comprises: (a) an expandable and collapsible frame member; (b)optionally, a protective cover or sleeve for partially encasing theframe member; and (c) means for (i) expanding the frame member, (ii)retaining the frame member in an expanded configuration, and (iii)collapsing the expanded frame member.

When the frame member is in a collapsed state, the pessary may be easilyinserted into the vagina. Once in place, the frame member is expanded,and prior to removal of the pessary, the frame member is returned to acollapsed state.

In a second embodiment, the inventive vaginal pessary basicallycomprises: (a) an open, substantially cone-shaped, collapsible framemember, the frame member being biased to an open position and comprisinga central hub, and a plurality of flexible and resilient spokesemanating from the central hub; (b) a flexible and resilient sheet-likematerial connecting the spokes of the frame member; and (c) withdrawalmeans attached to the central hub of the frame member.

The frame member is collapsed prior to insertion of the pessary into thevagina, and once in place in the vagina, the frame member is allowed toadopt an open, substantially conical configuration. Prior to removal ofthe pessary, the frame member is returned to a collapsed configuration.

In a third embodiment, the inventive vaginal pessary is a yieldablyextensible, self-retracting pessary that basically comprises: (a) anelongate cylindrical body having a distal end and a proximal end; (b)optionally, a protective cover or sleeve for encasing the elongatecylindrical body; and (c) withdrawal means attached to the proximal endof the elongate cylindrical body. Prior to insertion into the vagina,the pessary is straightened and, upon proper placement in the vagina, isallowed to adopt a coiled configuration.

Other features and advantages of the invention will be apparent to oneof ordinary skill from the following detailed description andaccompanying drawings. Unless otherwise defined, all technical andscientific terms used herein have the same meaning as commonlyunderstood by one of ordinary skill in the art to which this inventionbelongs. All publications, patent applications, patents and otherreferences mentioned herein are incorporated by reference in theirentirety. In case of conflict, the present specification, includingdefinitions, will control. In addition, the materials, methods, andexamples are illustrative only and not intended to be limiting.

BRIEF DESCRIPTION OF THE DRAWINGS

Particular features of the disclosed invention are illustrated byreference to the accompanying drawings in which:

FIG. 1 is a partial cut-away side view of the first embodiment of thevaginal pessary of the present invention showing the frame member in itsexpanded configuration;

FIG. 2 is a partial cut-away side view of the vaginal pessary of FIG. 1showing the frame member in its collapsed state;

FIG. 3 is an enlarged cross-sectional side view of the vaginal pessaryshown in FIG. 1;

FIG. 4 is a side view of a device for inserting and removing the vaginalpessary of FIG. 1 into and out of the vagina;

FIG. 5 is a diagrammatic cross-sectional view of the female urogenitalsystem showing the vaginal pessary of FIG. 1 in place within the vagina.

FIG. 6 is a cross-sectional side view of a variation of the secondembodiment of the vaginal pessary of the present invention showing theframe member in its normally open state;

FIG. 7 is a cross-sectional side view of another variation of the secondembodiment of the vaginal pessary of the present invention also showingthe frame member in its normally open state;

FIG. 8 is a side view of the vaginal pessary of FIG. 6 showing the framemember in a collapsed state;

FIG. 9 is a side view of a device for inserting and removing the vaginalpessary of FIGS. 6 and 7 into and out of the vagina;

FIG. 10 is a diagrammatic cross-sectional view of the female urogenitalsystem showing the vaginal pessary of FIG. 6 in place within the vagina;

FIG. 11 is a top perspective view of a variation of the third embodimentof the vaginal pessary of the present invention showing the pessary inits normally flat or planar, coiled configuration;

FIG. 12 is a top plan view of the pessary shown in FIG. 11;

FIGS. 13 and 14 are side perspective views of other variations of thethird embodiment of the inventive vaginal pessary showing each pessaryin its normally non-planar, coiled configuration;

FIG. 15 is a side view of a device for inserting and removing thevaginal pessary of FIGS. 11, 13 and 14 into and out of the vagina; and

FIG. 16 is a diagrammatic cross-sectional view of the female urogenitalsystem showing the vaginal pessary of FIG. 11 in place within thevagina.

BEST MODE FOR CARRYING OUT THE INVENTION

As noted above, the vaginal pessary of the present invention allows apatient to insert and remove the pessary herself on a daily basis, or asneeded, thereby facilitating good hygiene and thus reducing oreliminating common pessary related complications (e.g., irritation,bleeding, malodorous discharge, erosion). The inventive pessary remainsfirmly anchored in the vaginal cavity during movement, and effectivelycounters the effects of any prolapsing organ.

In a first embodiment, the vaginal pessary of the present invention iscapable of expanding and collapsing and basically comprises:

-   -   (a) an expandable and collapsible frame member, wherein the        frame member comprises:        -   (i) coaxial outer and inner elongated cylindrical members,            the outer elongated cylindrical member being slidably            disposed on the inner elongated cylindrical member and            having opposing upper and lower ends, with the upper end            terminating in, or fixably attached to, an upper bulb-shaped            hub, the inner elongated cylindrical member having opposing            upper and lower ends, with the lower end terminating in, or            fixably attached to, a lower bulb-shaped hub; and        -   (ii) a plurality of flexible and resilient spokes            surrounding the outer and inner elongated cylindrical            members, and fixably attached to both the upper and lower            hubs;    -   (b) optionally, a protective cover or sleeve for partially        encasing the frame member; and    -   (c) means for (i) expanding the frame member, (ii) retaining the        frame member in an expanded configuration, and (iii) collapsing        the expanded frame member.

The vaginal pessary of this first embodiment has, in its expanded state,a maximum outer diameter or major axis that exceeds the midsagittalvaginal diameter, and is sufficiently stiff to resist deforming stressesexerted by the vaginal wall muscles.

While the inventive vaginal pessary may adopt any suitable shape, in apreferred embodiment, as best shown in FIGS. 1 to 3, the inventivevaginal pessary adopts an elongated prolate ellipsoid-like shape when ina collapsed state (see FIG. 2), and an oblate ellipsoid-like shape whenin an expanded state (see FIGS. 1 and 3).

The inventive vaginal pessary in its collapsed state is sized ordimensioned to facilitate insertion into and withdrawal from the vagina.In a preferred embodiment, the collapsed vaginal pessary has a minoraxis length or width ranging from about 2.5 to about 4.5 centimeters(cm) and a major axis length or height ranging from about 5.0 to about9.0 cm.

The inventive vaginal pessary in its expanded state is sized ordimensioned to suit the individual requirements of the patient. Whereeach patient has different vaginal dimensions and different requirementsin terms of the pressure that the inventive vaginal pessary must exertin order to achieve its objectives, it is intended that the vaginalpessary of this first embodiment be available in a number of sizes, withminor axis lengths or heights in the expanded state ranging from about2.5 to about 4.5 cm and major axis lengths or widths ranging from about5.0 to about 9.0 cm.

As alluded to above, the expandable and collapsible frame member issufficiently rigid to retain its shape against the pressure exerted bythe vaginal walls, while having sufficient flexibility and resiliency tobe collapsible for introduction into and removal from the vagina. In apreferred embodiment, the coaxial outer and inner elongated cylindricalmembers (including the upper and lower hubs) are formed from a rigidmaterial such as stainless steel, while the flexible and resilientspokes are formed from shape memory alloys or other material exhibitingsimilar super-elastic characteristics.

In order to facilitate uniform spacing between the spokes when theinventive pessary is in its expanded state, the frame member may furthercomprise a flexible and resilient band affixed mid-way along an outer orinner surface of each spoke.

A protective cover or sleeve may be used to partially encase the framemember, covering the spokes while leaving the upper and lower hubsexposed. The protective cover or sleeve may be made of a flexible,resilient and impermeable biocompatible material (i.e., materials thatdo not incite toxic reactions). Suitable materials include polyethylene,polyvinyl chloride, urethane, silicone rubber, and the like.

The expanding/retaining/collapsing means of the vaginal pessary of thisfirst embodiment is not limited and may be any suitable mechanicaland/or electronic means.

Referring now to FIGS. 1 to 3 in detail, reference numeral 10 has beenused to generally designate a preferred first embodiment of theinventive vaginal pessary in which the expanding/retaining/collapsingmeans is mechanical in nature. In this preferred embodiment, vaginalpessary 10 generally comprises:

-   -   (a) an expandable and collapsible frame member 12, which        comprises:        -   (i) coaxial outer and inner elongated cylindrical members            14, 16, the outer elongated cylindrical member 14 having            opposing upper and lower ends, with the upper end            terminating in, or fixably attached to, an upper bulb-shaped            hub 18, the inner elongated cylindrical member 16 having            opposing upper and lower ends, with the lower end            terminating in, or fixably attached to, a lower bulb-shaped            hub 20 having a small central opening 22; and        -   (ii) a plurality of flexible and resilient spokes 24            surrounding the outer and inner elongated cylindrical            members 14, 16, and fixably attached to both the upper and            lower hubs 18, 20;    -   (b) a protective cover or sleeve 26 for partially encasing the        frame member 12; and    -   (c) expanding/retaining/collapsing means 28, which comprises:        -   (i) a helical spring or spring-like member 30 surrounding            the coaxial outer and inner elongated cylindrical members            14, 16;        -   (ii) a cord, string or tape 32 having a length ranging from            about 15 cm to about 30 cm, attached to an inner surface of            upper hub 18, which extends through cylindrical members 14,            16 and out through opening 22 of lower hub 20;        -   (iii) locking/releasing mechanism 34 comprising a projection            36 emanating from the upper end of the inner elongated            cylindrical member 16, an opening 38 in upper hub 18 that is            shaped to receive projection 36, and a projection 40            emanating from an outer surface of lower hub 20.

Device 42, which is shown in FIG. 4, is used in conjunction with pessary10 and comprises an elongate cylindrical body 44 having a slot-shapedopening 46 that extends along the longitudinal axis of body 44 andterminates in an opening 48 shaped to receive projection 40 of lower hub20. Device 42 is used by a patient to insert pessary 10, while in acollapsed configuration, into the vagina and when properly placed withinthe vagina, to expand the pessary 10 and to lock the pessary 10 in itsexpanded configuration. Device 42 is also used by the patient tocollapse the pessary 10 prior to removal from the vagina.

More specifically, prior to insertion into the vagina, a patient wouldline up the opening 48 on device 42 with the projection 40 on lower hub20 of pessary 10, while guiding cord, string or tape 32 through theslot-shaped opening 46 of device 42. The patient would then position thepessary 10 at the mouth of the vagina, apply an upward force on device42 to push pessary 10 into the vagina, and once properly positioned,expand pessary 10 by simultaneously applying upward pressure on device42, while pulling down on the cord, string or tape 32. Once fullyexpanded, the patient would rotate device 42 and concomitantly innerelongate cylindrical member 16 until projection 36 is fully engaged inopening 38 of upper hub 18, thereby locking pessary 10 in its expandedconfiguration.

When the patient is ready to remove vaginal pessary 10, she would insertthe device 42 into the vagina, line up the opening 48 on device 42 withthe projection 40 on lower hub 20 of pessary 10, and rotate device 42and concomitantly inner elongate cylindrical member 16 until projection36 fully disengages from opening 38 of upper hub 18, thereby collapsingpessary 10. Collapsed pessary 10 and device 42 would then be easily andcomfortably removed from the vagina by the patient applying a gentledownward force on cord, string or tape 32. The pessary 10 and device 42would then be cleaned and stored until they were needed again by thepatient.

As best shown in FIG. 5, which is a diagrammatic cross-sectional view ofthe female urogenital system showing expanded vaginal pessary 10 inplace within the vagina, expanded vaginal pessary 10 fully andeffectively counters the effects of any prolapsing organ, such as theurinary bladder, uterus or rectum, into the vagina or vaginal vault.

Referring now to FIGS. 6 to 10, in detail, reference number 50 has beenused to generally designate two variations of a second embodiment of thevaginal pessary of the present invention. In this second embodiment,vaginal pessary 50 has an inverted, umbrella-like appearance andbasically comprises:

-   -   (a) an open, substantially cone-shaped, collapsible frame member        52, the frame member 52 being biased to an open position and        comprising an inverted substantially dome-shaped central hub 54,        and a plurality of flexible and resilient spokes 56 emanating        from the central hub 54, with each spoke 56 having a blunt,        rounded or shaped proximal end 58;    -   (b) a flexible and resilient sheet-like material 60 connecting        the spokes 56 of the frame member 52; and    -   (c) withdrawal means 62 attached to the central hub 54 of frame        member 52.

As best shown in FIGS. 6 and 7, collapsible frame member 52 may besymmetric or asymmetric in design. For example, the transversecross-sectional shape of collapsible frame member 52, as defined by theopening formed by the proximal ends 58 of spokes 56, may be circular(see FIG. 6) or oval, semi-oval, elliptical (see FIG. 7), orsemi-elliptical. Where the asymmetrical design shown in FIG. 7 moreclosely conforms to vaginal anatomy, this variation may prove to be morecomfortable to patients.

Similar to that noted above with respect to the first embodiment,vaginal pessary 50 in its normally open state has a maximum outerdiameter that exceeds the midsagittal vaginal diameter and issufficiently stiff to resist deforming stresses exerted by the vaginalwall muscles while in place in the vagina.

Vaginal pessary 50, in its collapsed state, fits inside any appropriateinsertion/withdrawal tool or device, such as that shown in FIG. 9.Preferably, vaginal pessary 50 has a maximum outer diameter or width inits collapsed state that does not exceed 4.5 cm.

Vaginal pessary 50, in its normally open state, is sized or dimensionedto suit the individual requirements of the patient. It is intended thatthe vaginal pessary of this second embodiment be available in a numberof sizes, with maximum outer diameters ranging from about 5.0 to about9.0 cm, and maximum heights ranging from about 2.5 to about 4.5 cm.

As alluded to above, the frame member 52 of vaginal pessary 50 issufficiently rigid to retain its open, substantially conical shapeagainst the pressure exerted by the vaginal walls, while havingsufficient flexibility to be collapsible for introduction into andremoval from the vagina. In a preferred embodiment, the invertedsubstantially dome-shaped central hub 54 is formed from a flexible,biocompatible material selected from the group of polyethylene,polyvinyl chloride, urethane, silicone rubber, and the like, while thespokes 56, which radiate from within central hub 54, are formed from arigid material such as stainless steel.

Flexible and resilient sheet-like material 60, which connects (andpreferably also coats) the spokes 56 of frame member 52, is a thin,membrane-like, biocompatible material that folds inward upon collapse offrame member 52 (see FIG. 8). In a preferred embodiment, material 60 isformed from a material selected from the group of polyethylene,polyvinyl chloride, urethane, silicone rubber, and the like.

Withdrawal means 62, which is attached to central hub 54 of frame member52 may be any device for physically withdrawing pessary 50 from thevagina. These devices, which are mentioned above in relation to thefirst embodiment as including cords, strings and tapes, may be made ofany suitable material known in the prior art including, but are notlimited to, cotton, cellulose, rayon, polyolefin (e.g., polyethylene,polypropylene), nylon, silk and polyester. In a preferred embodiment,withdrawal means 52 is a cord or string made from cotton, rayon orpolypropylene that has a length ranging from about 10 to about 20 cm.

Insertion and removal of vaginal pessary 50 may be easily andcomfortably performed by a patient on a daily basis, or as needed, usinginsertion/withdrawal device 64 (see FIG. 9). Insertion/withdrawal device64 comprises: an elongate cylindrical body 66 having an inner diameterthat is slightly larger than the maximum outer diameter of collapsedpessary 50, and having a slot-shaped opening 68 located along itslongitudinal axis; and a plunger 70. To insert pessary 50 into thevagina, the patient would remove plunger 70 from device 64, draw thepessary 50 into the device 64 using withdrawal means 62, and then thepatient would replace plunger 70. Device 64 would then be inserted intothe vagina and upon proper placement therein, the patient would push onplunger 70 to eject vaginal pessary 50 from device 64, whereupon itwould immediately assume its normal open, substantially conicalconfiguration in the vagina (see FIG. 10), with proximal ends 58 ofspokes 56 contacting the inner wall of the vagina. Device 64 would thenbe removed by the patient from the vagina, cleaned and stored.

When the patient is ready to remove the vaginal pessary 50, she wouldgrasp withdrawal means 62 with one hand and re-insert device 64 (withoutplunger 70) into the vagina with the other hand, while guidingwithdrawal means 62 through slot-shaped opening 68 of device 64. Oncedevice 64 contacted pessary 50 within the vagina, the patient wouldslowly urge pessary 50 into device 64 by applying a downward force onwithdrawal means 62. Once pessary 50 had been completely drawn insidedevice 64, device 64 would be removed from the vagina, the pessary 50and device 64 cleaned and the pessary 50 stored within device 64 untilit was needed again by the patient.

As best shown in FIG. 10, which is a diagrammatic cross-sectional viewof the female urogenital system showing open vaginal pessary 50 (asshown in FIG. 6) in place within the vagina, vaginal pessary 50 fullyand effectively counters the effects of any prolapsing organ, such asthe urinary bladder, uterus or rectum, into the vagina or vaginal tovault.

Referring now to FIGS. 11 to 16, in detail, reference number 72 has beenused to generally designate three variations of a third embodiment ofthe vaginal pessary of the present invention. In this third embodiment,vaginal pessary 72 is a yieldably extensible, self-retracting vaginalpessary that basically comprises:

-   -   (a) an elongate cylindrical body 74 having a distal end 76 and a        proximal end 78, the elongate cylindrical body 74 normally        assuming a coiled configuration;    -   (b) optionally, a protective cover or sleeve 80 for encasing the        elongate cylindrical body 74; and    -   (c) withdrawal means 82 attached to the proximal end 78 of the        elongate cylindrical body 74.

By way of example, and as best shown in FIGS. 11 to 14, elongatecylindrical body 74 may normally assume a planar or flat, coiledconfiguration (FIGS. 11 and 12), a non-planar, substantiallydiamond-shaped, coiled configuration (FIG. 13), or a non-planar,substantially cone-shaped, coiled configuration (FIG. 14).

Vaginal pessary 72, when in its normally coiled state, has a maximumouter diameter that exceeds the midsagittal vaginal diameter and issufficiently stiff to resist deforming stresses exerted by the vaginalwall muscles while in place in the vagina.

The elongate cylindrical body 74 of vaginal pessary 72, when forciblyextended or stretched out, fits inside any appropriateinsertion/withdrawal tool or device, such as that shown in FIG. 15.Preferably, the elongate cylindrical body 74, when forcibly elongated,has a maximum outer diameter that does not exceed 2.5 cm.

Vaginal pessary 72, in its normally coiled state, is sized ordimensioned to suit the individual requirements of the patient. It isintended that the vaginal pessary of this third embodiment be availablein a number of sizes, with maximum outer pessary diameters ranging fromabout 5.0 to about 9.0 cm, and pessary heights ranging from about 2.5 toabout 4.5 cm.

As noted above, the elongate cylindrical body 74 assumes a coiledconfiguration when relaxed, and requires the application of an externalforce in order to assume a different configuration, such as beingelongated. Conversely, when elongate cylindrical body 74 is elongated orotherwise manipulated by a force so that it is no longer in a relatedconfiguration, it continuously exerts an opposing force until itreassumes the relaxed configuration.

Elongate cylindrical body 74 may be prepared from any “elastic memory”or “elastic shape memory” material. The terms “elastic memory” and“elastic shape memory” are used herein to mean a material that hasspring-like properties, that is, a material capable of being deformed byan applied stress and springing back to its original unstressed shape orconfiguration when that stress is removed.

In one preferred embodiment, elongate cylindrical body 74 is formed froma flexible, thermoplastic material that is thermoformed into a coiledshape and is biased to retain that shape, or retract into it, because ofits elastic memory. In a more preferred embodiment, elongate cylindricalbody 74 is formed from polyvinyl chloride.

In another preferred embodiment, elongate cylindrical body 74 is formedfrom a helical spring, or from an elongated spring metal ribbon orblade, that normally adopts a coiled configuration as described above.

Elongate cylindrical body 74 may have blunt, rounded or shaped distaland proximal ends 76, 78. In a preferred embodiment, as best shown inFIG. 12, elongate cylindrical body 74 normally assumes a flat, coiledconfiguration, and distal end 76 of elongate cylindrical body 74 isshaped to conform to the substantially circular outer circumference ofthe vaginal pessary.

In another preferred embodiment, contiguous side edges of body 74 may beadapted to mate or interconnect as the body 74 returns to its relaxedposition.

A protective cover or sleeve 80 may be used to encase the elongatecylindrical body 72. Protective cover or sleeve 80 may be made of aflexible and impermeable biocompatible material. Suitable materialsinclude polyethylene, polyvinyl chloride, urethane, silicone rubber, andthe like.

Withdrawal means 82, which is attached to the proximal end 78 of theelongate cylindrical body 74, may be any device for physicallywithdrawing pessary 72, from the vagina. In a preferred embodiment,withdrawal means 82 is a cord or string having a length ranging fromabout 18 to about 35 cm that is made from cotton, rayon orpolypropylene.

In a more preferred third embodiment, as best shown in FIG. 12, vaginalpessary 72 comprises:

-   -   (a) an elongate cylindrical body 74 formed from a flexible,        thermoplastic material that has been thermoformed into a flat,        coiled shape, wherein the elongate cylindrical body 74 is biased        to retain such a flat, coiled shape;    -   (b) a silicone protective cover or sleeve 80 that fully encases        the elongate cylindrical body 74; and    -   (c) a cord or string (not shown in FIG. 12) made from cotton,        rayon or polypropylene that is attached to the proximal end of        the elongate cylindrical body.

Insertion and removal of vaginal pessary 72 may be easily andcomfortably performed by a patient on a daily basis, or as needed, usinginsertion/withdrawal device 84 (see FIG. 15). Insertion/withdrawaldevice 84 comprises: an elongate cylindrical body 86 having an innerdiameter that is slightly larger than the outer diameter of the elongatecylindrical body 74 of vaginal pessary 72, and having a slot-shapedopening 88 located along its longitudinal axis; and a plunger 90. Toinsert pessary 72, into the vagina, the patient would remove plunger 90from device 84, draw the pessary 72, into the device 84 using withdrawalmeans 82, and then the patient would replace plunger 90. Device 84 wouldthen be inserted into the vagina and upon proper placement therein, thepatient would push on plunger 90 to eject vaginal pessary 72, fromdevice 84, whereupon it would immediately assume its normal coiledconfiguration in the vagina (see FIG. 16). Device 84 would then beremoved by the patient from the vagina, cleaned and stored.

When the patient is ready to remove the vaginal pessary 72, she wouldgrasp withdrawal means 82 with one hand and re-insert device 84 (withoutplunger 90) into the vagina with the other hand, while guidingwithdrawal means 82 through the slot-shaped opening 88 of device 84.Once device 84 was in place within the vagina, the patient would slowlyurge pessary 72, into device 84 by applying a downward force onwithdrawal means 82. Once pessary 72, has been completely drawn intodevice 84, device 84 would be removed from the vagina, the pessary 72,and device 84 cleaned and the pessary 72, stored within device 84 untilit was needed again by the patient.

As best shown in FIG. 16, which is a diagrammatic cross-sectional viewof the female urogenital system showing coiled vaginal pessary 72 inplace within the vagina, vaginal pessary 72 fully and effectivelycounters the effects of any prolapsing organ, such as the urinarybladder, uterus or rectum, into the vagina or vaginal vault.

While various embodiments of the present invention have been describedabove, it should be understood that they have been presented by way ofexample only, and not limitation. Thus, the breadth and scope of thepresent invention should not be limited by any of the exemplaryembodiments.

1. A vaginal pessary, which comprises: an elongate cylindrical bodyhaving a distal end and a proximal end, which is yieldably extensibleand self-retracting; and withdrawal means attached to the proximal endof the elongate cylindrical body.
 2. The vaginal pessary of claim 1,wherein the elongate cylindrical body normally assumes: (i) a planar orflat, coiled configuration; (ii) a non-planar, substantiallydiamond-shaped, coiled configuration; or (iii) a non-planar,substantially cone-shaped, coiled configuration.
 3. The vaginal pessaryof claim 1, which when forcibly elongated has a maximum outer diameterof less than or equal to about 2.5 centimeters.
 4. The vaginal pessaryof claim 1, which when in its normally coiled state has a maximum outerdiameter or width ranging from about 5.0 to about 9.0 centimeters, and aheight ranging from about 2.5 to about 4.5 centimeters.
 5. The vaginalpessary of claim 1, which is formed from a flexible, thermoplasticmaterial having an elastic memory that is thermoformed into a coiledshape and is biased to retain that shape, or retract into it, because ofits elastic memory.
 6. The vaginal pessary of claim 1, which is formedfrom a helical spring or from an elongated spring metal ribbon or blade,which normally adopts a coiled configuration
 7. The vaginal pessary ofclaim 1, which further comprises a protective cover or sleeve forencasing the elongate cylindrical body.
 8. The vaginal pessary of claim1, wherein the withdrawal means comprises a cord or string having alength ranging from about 18 to about 35 centimeters.
 9. A device foruse with the vaginal pessary of claim 1, which comprises an elongatecylindrical body having a slot-shaped opening located along itslongitudinal axis, and a plunger slidably arranged within a portion ofthe elongate cylindrical body.